Issue Date: February 15, 2010
Failed Malaria Drugs
As many as 40% of the antimalarial drugs in three African countries are of substandard quality, new tests have found. These initial results raise concerns that ineffective drugs could lead to more drug-resistant strains of Plasmodium falciparum, which causes the most virulent form of malaria.
The data come from a 10-country study—the Quality of Antimalarials in Sub-Saharan Africa—being run by the World Health Organization and the U.S. Agency for International Development. A study partner, the U.S. Pharmacopeial Convention (USP), a nonprofit standards-setting group, is coordinating the testing.
So far, about 44% of antimalarial medicines sampled in Senegal, 30% in Madagascar, and 26% in Uganda failed testing. The focus of the sampling has been on artemisinin-based combination therapies, which WHO recommends as the first-line treatment, and sulfadoxine-pyrimethamine products, which are often used to prevent the disease during pregnancy.
The failing drugs lacked the correct amount of active pharmaceutical ingredient, did not dissolve properly in the body, or had unacceptable levels of potentially harmful impurities. Products tested came from public and regulated private sources, as well as informal markets.
“Although alarming, this study offers extremely valuable information that has already been shared with those countries in the hope that local regulatory bodies will focus their attention on products, brands, and geographical locations where substandard medicines were found to pose the biggest threats,” says Patrick Lukulay, director of the study program at USP. Besides substandard malaria medicines, the program hopes to uncover subpar and counterfeit HIV and tuberculosis drugs in Africa, Asia, Eastern Europe, and Latin America.
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